The present invention relates generally to an ultrasonic surgical device delivery system and particularly relates to apparatus and methods for facilitating attachment and detachment of an ultrasonically-actuated blade/coupler assembly and an acoustical mount therefor.
Ultrasonic surgical devices for performing a variety of surgical procedures are well known. Generally, these surgical devices are hand-held instruments connected to a source of ultrasonic energy. The ultrasonic energy is transmitted through a connection or mount between the ultrasonic energy source and a hand-held coupler which mounts the surgical tool, for example, a surgical blade mounted at the tip of the hand-held coupler. Ultrasonic energy is therefore transmitted through the coupler to the surgical blade to facilitate a precise surgical incision.
Ultrasonic surgical devices, however, are not without problems when used. For example, an acoustically-actuated surgical device should be used in a sterile field. Ready attachment and detachment of the surgical device relative to the ultrasonic energy source is highly desirable. Traditionally, a screw-type mechanism has been employed to secure the ultrasonic surgical device to its acoustical mount so that the ultrasonic energy may be transmitted through the mount to the surgical device. Because of the need for a sterile environment, the surgical device must be readily attached to the acoustical mount for use in a manner which maintains the sterile field. Quick detachment of the surgical device from its acoustical mount after use for sterilization or disposal is also highly desirable.
It will be appreciated that the connection between the surgical device and the ultrasonic energy source requires a tight union so that ultrasonic energy may be efficiently transmitted to the device at the desired power levels. When a screwthread is used, the surgical device is often over-tightened to the acoustical mount by the surgeon, nurse or technician in order to ensure that ultrasonic energy is properly transmitted to the surgical device. Typically, this causes difficulties, not only when attaching the surgical device and its mount, but also when detaching the surgical device from the mount after use, i.e., it is often overtightened and therefore difficult to detach. Also, when attaching and detaching the surgical device and the acoustical mount, there is the obvious danger of injury to the doctor, nurse or technician as a result of contact with the surgical device itself, e.g., the blade. Additionally, it is very difficult for surgeons, nurses or technicians to connect and disconnect the surgical device and its acoustical mount in a sterile field using typical fastening devices such as pliers, wrenches and the like and without causing injury.
According to the present invention, there is provided an ultrasonic surgical device delivery system that overcomes the foregoing and other problems associated with the attachment and detachment of an ultrasonic surgical device and its acoustical mount and provides apparatus and methods facilitating attachment and detachment of an ultrasonic surgical device and an acoustical mount therefor affording various advantages in construction, operation and use in comparison with traditional prior systems. Particularly, the present invention, in a preferred embodiment thereof, provides an adaptor having a generally cylindrical sleeve and a radial flange at one end, the flange having a conical surface for directing the surgical device into the sleeve. The surgical device may, for example, include a blade/coupler having a surgical blade at one end and an internally threaded female connection at its opposite end for connection to the acoustical mount. Flats are provided along both the coupler of the surgical device and the interior of the adaptor sleeve whereby, when the adaptor receives the blade/coupler, the adaptor and coupler may be rotated as a unit.
Two different embodiments for rotating the adaptor and hence adaptor/coupler combination are provided. In one embodiment, a separate cooperating cylindrical member having a radially extending end flange is received over the sleeve of the adaptor and is rotatable relative to the adaptor. In this form, the rearwardly facing annular surface of the adaptor flange is provided with a plurality of cam surfaces which form part of a circular ratchet mechanism. The cam surfaces may, for example, comprise ramps in each quadrant of the rearwardly facing annular surface and which ramps terminate in end stops. The end flange of the cylindrical member preferably has a pair of cam followers, e.g., end projections, for engaging two of the cam surfaces along the rearwardly facing annular surface of the adaptor flange, the projections being provided at diametrically opposed locations. Additionally, the cylindrical member is provided with diametrically opposed, radially extending wings preferably extending from the end flange the full length of the member, such wings facilitating manual purchase of the member and its rotation relative to the adaptor. The wings are preferably circumferentially spaced 90.degree. from the end projections. In this manner, the portions of the end flanges of the cylindrical member carrying the projections may resiliently flex in an axial rearward direction. The cylindrical member is received about the adaptor sleeve and secured against axial movement relative thereto by spring-biased fingers at the end of the adaptor sleeve remote from the adaptor flange.
Preferably, the blade/coupler, adaptor and cylindrical member are provided in a sterile package, in assembly or not, as desired. In use, the blade/coupler, adaptor and member are removed from their sterile packaging and, if not assembled, are assembled one to the other and to the blade/coupler. Particularly, the blade end of the blade/coupler surgical device is inserted into the adaptor sleeve, the conical end surface of the adaptor facilitating that insertion by guiding the blade into the sleeve. The blade/coupler is also rotationally aligned with the adaptor sleeve such that the flats on the coupler engage the flats within the bore of the sleeve. The interior edges of the conical surface engages stops carried by the blade/coupler limiting its axial movement into the adaptor. It will be appreciated that the blade is wholly received within the adaptor sleeve. Thus, the sleeve protects an individual against exposure to the blade during attachment or detachment of the device relative to the acoustical mount.
To attach the surgical device to the mount, the blade/coupler is threaded on the mount. When the coupler is loosely tightened to the mount, the wings on the cylindrical member are grasped and the member is rotated in the conventional screw-threading direction. The end projections on the member frictionally engage the cam surfaces, and consequently, the adaptor and member are rotatable as a unit to further tighten the blade/coupler to the acoustical mount. As the joint tightens and the resistance to further threading increases, the projections start to slide along the cam surfaces while continuing to apply torque to the adaptor and the coupler whereby the coupler is further tightened. Particularly, the end projections move up the ramps, causing the flange carrying the projections to resiliently flex or yield in an axial rearward direction and hence cause greater frictional engagement between the end projections and the cam surfaces. At a predetermined torque, the projections will move past the high points or trailing ends of the cam surfaces and spring back to engage the leading portions of the next cam surfaces. Thus, upon rotating the member further, a ratcheting action is provided at a predetermined torque value between the cylindrical member and the adaptor. In this manner, the individual attaching the blade/coupler to the acoustical mount will recognize that sufficient torque has been applied to the blade/coupler to ensure its connection with the acoustical mount in such manner that the ultrasonic energy will be efficiently transferred to the surgical device and this will be accomplished without over-tightening the connection. The adaptor and member are then removed from the blade/coupler assembly and the ultrasonic surgical device is ready for use.
To detach the surgical device from the acoustical mount after use, the adaptor and member are applied to the blade end of the device similarly as previously described. The cylindrical member, however, is rotated in the opposite direction, i.e., in a direction to unthread the blade/coupler from the acoustical mount. The projections on the member will thus engage the end stops of the cam surfaces and rotate the adaptor and coupler to provide the necessary unthreading action. Essentially unlimited torque may be applied to the member when rotated in the unthreading direction. Importantly, the unthreading action is provided with the blade completely encapsulated within the sleeve of the adaptor, thus protecting the individual removing the surgical device from its mount from cuts and puncture wounds. Once removed, the entire blade/coupler, adaptor and cylindrical member assembly may be thrown away. Alternatively, the adaptor and member sub-assembly may be removed from the blade/coupler, whereby the latter may be sterilized for reuse.
In another preferred embodiment of the present invention, the blade/coupler adaptor comprises an integrated one-piece unit formed of plastic material and which serves as the complete wrench, without the addition of a separate member as in the prior two-piece embodiment, for attaching and detaching the blade/coupler to and from the mount, respectively. More particularly, the adaptor includes a generally cylindrical sleeve with a flange at one end, together with flats along the interior of the adaptor sleeve, as previously described, for receiving the blade/coupler. In this form, however, a single unitary, generally radially projecting element or flange projects from one side of the sleeve. The element is generally rectilinear and extends parallel to the axis of the sleeve and from a position just behind, but spaced from, the flange. The element has a zone of weakness adjacent its attachment to the sleeve defining a hinge having an axis parallel to but spaced from the axis of the sleeve. The element is otherwise unconnected to the sleeve and flange and therefore may flex in opposite directions about the axis of the hinge.
A pair of projections extend from the back side of the flange for engagement by the forward edge portion of the element upon flexing movement in the opposite direction. One projection has a predetermined length in the axial direction such that when a predetermined magnitude of torque is applied by the element to the projection (and hence by the adaptor to the blade/coupler), the flange deflects under the applied load, thus moving the projection forwardly and out of the way of the element. Consequently, the element at a predetermined magnitude of applied torque may pivot past this projection. The length of the projection and thickness of the material forming the flange are predetermined to provide this deflection and movement of the element past the projection at a predetermined torque in the blade/coupler mount tightening direction.
The other projection has a greater axial extent and serves as an abutment or stop for the element when rotated in the opposite direction. Thus, to remove the blade/coupler from its mount, the blade/coupler is inserted into the sleeve and the element moved about its axis against the longer projection to rotate the adaptor and, hence, blade/coupler in a direction unthreading the blade/coupler from the mount. While a pair of elements, each associated with a pair of projections, may be provided, it is preferable to provide only one such element because it might be possible to move only one of the two elements past its projection whereby the proper magnitude of torque applied to the blade/coupler would not be of the predetermined value.
Another feature of this one-piece embodiment of the present invention resides in a rearwardly projecting portion of the sleeve, which has a wall thickness thinned down or reduced to permit inward deflection by finger pressure. That is, the end of the sleeve remote from the flange may be compressed inwardly by finger pressure. This facilitates removal of the blade/coupler from the adaptor by creating an undercut to ease pulling the adaptor from the blade/coupler.
With the foregoing features in mind, it will be readily seen that there are significant advantages and benefits afforded by the system of the present invention. For example, the surgical blade during attachment and detachment from the acoustical mount is completely encapsulated within the sleeve of the adaptor, thereby preventing injury to the individual performing those tasks. Additionally, the blade/coupler, together with the attaching and detaching mechanism, may be provided as part of a sterile package for single use and disposal. Further, the ratcheting action during attachment, described above in connection with the two-piece embodiment, and the pivoting of the element past the projection, as described above with respect to the one-piece embodiment, ensure that sufficient torque has been applied to the coupler so that the requisite ultrasonic energy will be efficiently transmitted from the ultrasonic source to the surgical device. Further tightening beyond the predetermined torque is thus not necessary and the problems associated with over-tightening are completely eliminated. The ratchet and pivoting mechanism also signals the individual attaching the device to the mount that sufficient tightness has been achieved whereby over-tightening and difficult removal is prevented. Additionally, during removal, the same delivery system is used. The one-way ratchet and the larger projection of the first and second embodiments, respectively, also enable virtually unlimited torque to be applied to the coupler in the reverse unthreading direction to facilitate its removal from the acoustical mount. Further, when removed, the adaptor and member, or the unitary adaptor, may remain attached to the blade/coupler throughout disposal to provide a protective enclosure for the blade, thereby avoiding accidents resulting from the sharp edge of the blade and transmission of infectious diseases. Both the integrated one-piece adaptor and the two-piece unit are also readily and easily used and manufactured and may be provided inexpensively of plastic materials.
Accordingly, and in accordance with a preferred embodiment of the present invention, there is provided apparatus for attaching a surgical device to a mount wherein the surgical device includes a coupler carrying a surgical tool comprising an adaptor including a sleeve for receiving the surgical tool and a flange adjacent one end of the sleeve, first means carried by the adaptor and engageable with the coupler when the surgical tool is received by the adaptor for rotating the coupler upon rotation of the adaptor and second means carried by the adaptor for rotating the adaptor to rotate the coupler. Also provided are means cooperable between the second means and the adaptor flange and responsive to movement of the second means in one direction for limiting the torque applied by the adaptor to the coupler to a predetermined magnitude thereof when the surgical tool is being attached to the mount. Third means are cooperable between the second means and the adaptor, and responsive to movement of the second means in the opposite direction, for applying a torque to the adaptor and coupler in the opposite direction in excess of the predetermined torque.
In a further preferred embodiment according to the present invention, there is provided apparatus for attaching a surgical device to a mount wherein the surgical device includes a coupler carrying a surgical tool comprising an adaptor including an elongated sleeve, having an axis, for receiving the surgical tool, a flange having an abutment, and guide surfaces carried by the adaptor and engageable with the coupler when the surgical tool is received by the adaptor for rotating the coupler upon the rotation of the adaptor. A generally radially extending element is carried by the adaptor for rotating the adaptor to rotate the coupler, the element being movable in opposite directions about an axis non-coincident with the axis of the sleeve and cooperable with the abutment in response to rotation of the element about its axis in one direction to rotate the adaptor and coupler about the axis of the sleeve and to limit the torque applied by the adaptor to the coupler to a predetermined magnitude thereof. A second abutment is carried by the flange, the element being cooperable with the second abutment in response to rotation of the element about its axis in the opposite direction for applying a torque to the adaptor and coupler in excess of the predetermined magnitude of torque.
In a further preferred embodiment according to the present invention, there is provided a method for attaching a surgical device to a mount wherein the surgical device includes a coupler carrying the surgical tool, comprising the steps of providing an adaptor having a sleeve containing the surgical tool and engageable with the coupler such that the coupler and adaptor may be rotated in one direction upon rotation of the adaptor in one direction, providing a member carried by the adaptor and movable in opposite directions, moving the member in one direction to rotate the adaptor and coupler in one rotary direction, limiting the torque applied by the adaptor to the coupler to a predetermined magnitude thereof in response to movement of the member in one direction, moving the member in the opposite direction to rotate the adaptor and coupler in the opposite rotary direction and applying a torque to the member when moving it in the opposite direction to rotate the adaptor and coupler in the opposite rotary direction, in excess of the predetermined magnitude of torque, thereby to detach the surgical device and the mount.
Accordingly, it is a primary object of the present invention to provide novel and improved apparatus and methods for attaching and detaching a surgical device relative to its energy source.